Clinical Trial Data Manager

3 weeks ago

London, United Kingdom University College London Hospitals NHS Foundation Trust Full time

Job summary

The Cancer Clinical Trials Unit at UCLH is looking to recruit a Data Manager to support a portfolioof Phase I-III clinical trials in the Genitourinary/Head and Neck Team. You may be required to coverother disease areas on a short-term or longer-term basis.

The post-holder will be required to deliver and verify trial-specific information to sponsors,support the team with the set-up of new clinical trials and assist as needed with the processing ofbiological samples, amongst other tasks. You will be part of supportive and dynamic team,working closely with clinical research staff. Whilst the position is administrative, the role is vital insupporting clinical research staff deliver excellent care to patients with cancer.

We are currently supporting hybrid remote working, allowing a combination of working fromhome and office-based working. Flexibility around on-site working is essential, and you may berequired to attend the office at relatively short notice to ensure that the service is covered.

We ideally want someone with experience of clinical research, knowledge of cancer, good verbaland written communication skills and some experience of working in a healthcare setting.

However, if you have some of these criteria and clear enthusiasm for the role, then please apply.

Main duties of the job

The post holder will:

Have a portfolio of trials for which they are responsible Complete data entry into case report forms for assigned trials as per protocols Ensure case report forms are completed are of high quality, accurate and sent in a timely manner Resolve issues with source data and anomalous data at the time of reporting, reviewing against previously reported data as well as local and national normal ranges. Prioritises workload to manage time effectively Process updated information and documents for the successful running of the study Create and maintain both paper and electronic trial site files Maintain list/database of up-coming, current and recently closed clinical trials Maintain electronic and paper list of accrual to trials Organise and prepare documentation for audits and monitoring visits. Process biological samples in the trials lab Liaise with the MDT, Principal and Sub Investigators, Sponsors, and support departments professionally and appropriately Obtain tumour block sample Upload scans as required by trial protocol Escalate issues to senior team members

The portfolio is very diverse, with a wide range of studies, to reflect the varied nature of the disease area in this age group. The successful applicant should be organised, pro-active and able to work autonomously, while also collaborating and communicating with the rest of the trials team and the doctor. Full duties are explained in the attached job description.

About us

University College London Hospitals NHS Foundation Trust (UCLH) is one of the most complex NHS trusts in the UK, serving a large and diverse population. We provide academically led acute and specialist services, to people from the local area, from throughout the United Kingdom and overseas. Our vision is to deliver top-quality patient care, excellent education, and world-class research.

We provide first-class acute and specialist services across eight sites:

University College Hospital (incorporating the Elizabeth Garrett Anderson Wing)

National Hospital for Neurology and Neurosurgery

Royal National ENT and Eastman Dental Hospitals

University College Hospital Grafton Way Building

Royal London Hospital for Integrated Medicine

University College Hospital Macmillan Cancer Centre

The Hospital for Tropical Diseases

University College Hospital at Westmoreland Street

We are dedicated to the diagnosis and treatment of many complex illnesses. UCLH specialises in women's health and the treatment of cancer, infection, neurological, gastrointestinal and oral disease. It has world class support services including critical care, imaging, nuclear medicine and pathology.

We are committed to sustainability and have pledged to become a carbon net zero health service, embedding sustainable practice throughout UCLH. We have set an ambitious target of net zero for our direct emissions by 2031 and indirect emissions by 2040.

Job description

Job responsibilities

For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.

The Cancer Clinical Trials Unit office is based in 250 Euston Rd and comprises of three main areas: Haematology, Oncology and Complex Pathways and it supports activity in the local Clinical Research Facility and the North Thames Local Comprehensive Research Network and Experimental Cancer Centre.

Each group is comprised of teams of research nurses, clinical trial practitioners and data managers and provides support to local Investigators wishing to conduct clinical trials and other high quality clinical research projects within UCLH.

Each team supports a process for agreeing a portfolio of research and ensures that trials are conducted to the highest standards and in accordance with UK legislation and the R&D Governance Framework. The aim of the Unit is to effectively use resources so as to ensure that patients have access to entry into clinical trials, as appropriate, and maintain the highest quality of care for patients.

Cancer Services sits within the Surgery and Cancer Board. It incorporates comprehensive outpatient, day care, and ambulatory care and inpatient services for the specialities of inpatient and outpatient oncology and Haematology.

Come and be a part of the best NHS trust in England to work for, according to our staff*

UCLH top trust to work at in England for the second year running : University College London Hospitals NHS Foundation Trust

*In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England for the second year in a row.

UCLH top trust to work at in England for the second year running University College London Hospitals NHS Foundation Trust.

Once again, UCLH has received the highest score of all general acute and acute/community NHS trusts in England for staff that would recommend us as a place to work.

Person Specification

Knowledge and Qualifications

Essential

Life Science degree Knowledge of drug development process and concept of clinical trials ledge of ICH GCP

Desirable

Knowledge of oncology and/or haematology

Experience

Essential

Experience of working under minimal supervision Experience of working as part of large teams Experience of working to deadlines Experience of independently carrying out a research project Experience of conducting clinical trials

Skills and Abilities

Essential

Proven ability to work under own initiative. Computer literacy to include experience of Word & Excel

Desirable

Knowledge of ICH GCP Knowledge of oncology and/or haematology

Communication

Essential

Proven ability to communicate effectively in writing.

Personal and People Development

Essential

Good eye for detail Ability to identify own training needs Displays desire for professional and personal development

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